Action Points

Explain that more than 40% of studies with negative findings were "spun" to convince readers of a more favorable result, while almost half of phrases considered to be positive "spin" weren't accompanied by any mention of a statistically significant result in positive trials.

Note that these studies were published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

VANCOUVER -- Although the term most often crops up in politics, "spin" exists in clinical trials with both positive and negative primary outcomes, researchers here said.

More than 40% of studies with negative findings were "spun" to convince readers of a more favorable result, Isabelle Boutron, MD, PhD, of Hopital Bichat-Claude Bernard in Paris, said at the Peer Review Congress here.

Even in trials with favorable outcomes, 49% of phrases considered to be positive "spin" weren't accompanied by any mention of a statistically significant result, according to Lisa Bero, PhD, of the University of California San Francisco.

"Scientists and sponsors are rarely neutral regarding their results," Boutron said. "They may be tempted consciously or unconsciously to bias the interpretation."

They defined spin as an attempt to "convince the reader that the treatment is important" even though the trial had nonsignificant findings.

It was considered spin, for example, if the author focused on statistically significant results of subgroup analyses or secondary outcomes, or if they interpreted the results as showing equivalence or comparable effectiveness, Boutron said.

She and colleagues found that just over 40% had spin in two or three sections of the text, typically the conclusion.

In that section, the spin most often focused on results that were actually statistically significant, rather than on the negative primary outcome, Boutron said.

"We considered it to be a high level of spin if there was no acknowledgement of the negative primary outcome, no uncertainty, or no recommendations for further research," she said.

In assessing trials with positive outcomes, Bero and graduate student Yolanda Cheng -- an undergraduate English major -- evaluated 35 randomized controlled trials submitted to the FDA as part of a New Drug Application.

All 35 positive conclusions strayed from the rest of the published literature on the drug, Bero said.

Bero and Cheng assessed the results and conclusions sections for rhetoric that suggested the drug was more effective or safer than the comparator. They looked for words or phrases that could be indicative of spin, including "significance" and "clinical."

They found a total of 695 rhetorical phrases in the 35 studies.

Almost half of the statements -- 49% -- were unaccompanied by any mention of a statistically significant result.

And 51% of statements included the word "significance," but only 72% of them were supported by the result of a statistical test, Bero said.

She and Cheng also found that any rhetoric regarding the safety of the drug was rarely supported by a statistical result.

"The rhetoric used to frame research results often overstates the efficacy and the safety of a drug," Bero said.

She called for a "structured discussion to deal with this problem of putting 'spin' on a study," and suggested that peer review could incorporate linguistic analysis as a means of deterring authors from 'spinning' results.

Boutron suggested that both her and Bero's studies provide a description of spin that "could be used by authors, reviewers, and readers to identify and avoid spin in articles."